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FDA Product Code

FDA Product Code KFC — Clearance Directory

Device Class
Class I
Assigned Panel
Hematology
21 CFR Citation
864.1850

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K875310 RETICULOCYTE STAIN Sigma Diagnostics, Inc. 1988-02-09 Traditional PDF ↗
K843919 SPOTTEST LOEFFLER METHYLENE BLUE STAIN Difco Laboratories, Inc. 1984-10-30 Traditional PDF ↗
K842785 STAIN, METHYLENE BLUE-EOSIN Reagent Laboratory, Inc. 1984-09-11 Traditional PDF ↗
K842926 METHYLENE BLUE STAIN, LOEFFLER E K Ind., Inc. 1984-09-11 Traditional PDF ↗
K842743 NEW METHYLENE BLUE N E K Ind., Inc. 1984-08-12 Traditional PDF ↗
K831502 NEPHROLYTE Flaitron Laboratories, Inc. 1983-07-18 Traditional PDF ↗
K770792 TUBE, STAIN, RETICULOCYTE, LARC Corning Medical & Scientific 1977-07-05 Traditional PDF ↗

Product code KFC · Class I · Hematology. Data: openFDA.